Generic Drug Maker Missed Exclusivity Period

(CN) – Teva Pharmaceuticals USA missed its chance for a 180-day period of exclusivity that the government grants to the first makers of a generic drug, a federal appeals court in Washington, D.C., ruled.

Teva filed for an abbreviated new drug application to produce a generic form of Risperdal. The Food and Drug Administration informed Teva that the patent for the drug had been delisted from the Orange Book of approved drugs. The trial court granted Teva an injunction to make the generic drug exclusively, but the D.C. Circuit blocked the injunction before delivering Judge Brown’s ruling. “Teva’s (drug application) did not meet the clear and unambiguous requirements of the statute because it did not and could not include a certification to a patent that claimed Risperdal,” Brown ruled. Brown rejected Teva’s argument that the patent and exclusivity period should be reinstated because the printed version of the Orange Book had not been updated to reflect the delisting of the patent. “The electronic version of the Orange Book reflected the withdrawal of the patent at least a month before Teva submitted its certification,” Brown noted.